Feasibility, Acceptability and Costs of a Multiple First-lines Artemisinin-based Combination Therapies

Malaria Clinical Trial

Official title:

Feasibility, Acceptability and Costs of a Strategy Deploying Multiple First-lines Artemisinin-based Combination Therapies for Uncomplicated Malaria: a Pilot Programme in the Health District of Kaya, Burkina Faso

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04265573
• Other study ID #: MFTs-ACTs-BF (PO17/01110)
• Status: Completed
• Start date: November 10, 2018
• Est. completion date: February 25, 2021

Study information

• Verified date: February 2020
• Source: Groupe de Recherche Action en Sante
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A simultaneous deployment of multiple first line therapies (MFT) for uncomplicated malaria using artemisisin based combination therapies as showed by theoretical models, may extend the useful therapeutic life of the current Artemisinin-based combination thérapies (ACTs) by reducing drug pressure and slowing the spread of resistance without putting life at risk. We therefore hypothesized that a simultaneous deployment of three ACTs targeting three segments of the population is feasible, acceptable and can achieve high coverage rate if potential barriers are well identified, well addressed and the key implementers are well-trained and adequately supported. To test this hypothesis, a quasi-experimental study will be conducted.

Description:

The study will be conducted through four overlapping phases: formative research phase, the MFTs deployment phase, the evaluation phase and the post-evaluation phase.

1. Formative research phase

1.1 Objective

Generate baseline information and to develop intervention tools for the pilot implementation of MFTs for uncomplicated malaria in the study area.

1.2 Design

Cross-sectional surveys using desk reviews, qualitative and quantitative research methods:

• Individual in-depth Interviews

• Focus group discussions

• Household surveys for the assessment of malaria-related morbidity and mortality at community level as well as the healthcare system utilisation

• Health facility-based surveys for malaria morbidity and mortality, antimalarial drugs and malaria rapid diagnostic tests availability.

1.3 Duration

Six months from obtaining the approval of the ethics committee for health research.

2. MFTs deployment phase

2.1 Objective

Implement the MFTs for uncomplicated malaria in the health district of Kaya that is feasible, acceptable and achieve high coverage rate.

2.2 Drugs deployment

Study ACTs and respective target populations:

• Artesunate-Pyronaridine for children less than five years of age

• Artemether-Lumefantrine for pregnant women

• Dihydroartemisinin-Piperaquine for individuals five years of age and above

NB: Community case management of malaria using Artemether-Lumefantrine as per National Malaria Control Program recommendation.

2.3 Duration

Twelve months including low and high malaria transmission seasons in the study area.

3. Monitoring and evaluation phase

3.1 Objectives

Assess the feasibility, the acceptability, the cost and the effects of the pilot MFTs pilot programme for uncomplicated malaria in the health district of Kaya.

3.2 Design

Cross-sectional surveys using desk review, qualitative and quantitative research methods:

• Individual in-depth Interviews

• Focus group discussions

• Household surveys for the assessment of malaria-related morbidity and mortality at community level as well as the healthcare system utilisation

• Health facility-based surveys for malaria-related morbidity and mortality, the availability and use of antimalarial drugs and malaria rapid diagnostic tests.

• Costs assessments.

3.3 Duration

Four months.

4. Post-evaluation phase

4.1 Objectives

Communicating and disseminating the findings of the pilot implementation of multiple first-lines artemisinin-based combination therapies for uncomplicated malaria in the health district of Kaya, Burkina Faso;

4.2 Methodology

• Feedback meetings for reporting to local communities

• National workshop aiming at reporting the programme findings

• Final report to be submitted to the donor

• Oral presentations of findings at congresses, conferences, seminars and publication of findings in peer-reviewed scientific journals

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150000
• Est. completion date: February 25, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Household survey

• Caregivers, adults, pregnant women

• Signed consent form

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Malaria

Locations

Country	Name	City	State
Burkina Faso	Groupe de Recherche Action en Santé	Ouagadougou

Sponsors (4)

Lead Sponsor	Collaborator
Groupe de Recherche Action en Sante	Institut de Recherche en Science de la Santé, Burkina Faso, Medicines for Malaria Venture, National Malaria Control Programme (NMCP), Burkina Faso

Country where clinical trial is conducted

Burkina Faso, 

References & Publications (2)

Boni MF, Smith DL, Laxminarayan R. Benefits of using multiple first-line therapies against malaria. Proc Natl Acad Sci U S A. 2008 Sep 16;105(37):14216-21. doi: 10.1073/pnas.0804628105. Epub 2008 Sep 9. — View Citation

Boni MF, White NJ, Baird JK. The Community As the Patient in Malaria-Endemic Areas: Preempting Drug Resistance with Multiple First-Line Therapies. PLoS Med. 2016 Mar 29;13(3):e1001984. doi: 10.1371/journal.pmed.1001984. eCollection 2016 Mar. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of favourable and unfavourable opinions from various profiles of informants about the MFT pilot program.	Data will be collected through qualitative surveys (FGDs; IDIs) and quantitative households surveys (KAP questionnaire) from various profiles of informants.	From the formative phase to the end of drugs deployment: 18 months duration.
Secondary	Proportion of community resources people with favourable opinions to the MFTs pilot program.	Data will be collected at community level through qualitative surveys (FGDs; IDIs) from various profiles of informants.	From the formative phase to the end of drugs deployment: 18 months duration.
Secondary	Proportion of community resources people with unfavourable opinions to the MFTs pilot program.	Data will be collected at community level through qualitative surveys (FGDs; IDIs) from various profiles of informants.	From the formative phase to the end of drugs deployment: 18 months duration.
Secondary	Average number of monitoring visits performed per annum	Data will be obtained though the health facility- based surveys.	Through the MFTs deployment phase: 12 months of duration.
Secondary	Average number of monitoring visits on which drugs stores have stock out of any dose of study ACTs per annum.	Data will be obtained though the health facility- based surveys.	Through the MFTs deployment phase: 12 months of duration.
Secondary	Average number of monitoring visits on which health facilities have stock out of mRDTs per annum.	Data will be obtained though the health facility- based surveys.	Through the MFTs deployment phase: 12 months of duration.
Secondary	Proportion of febrile episode seen at health facility level.	Data will be obtained through health facility- based surveys using registers of Health Facilities (HF).	Through the MFTs deployment phase: 12 months of duration
Secondary	Proportion of febrile episode seen at health facility level (HFL) within 24 hours	Data will be obtained through health facility- based surveys using registers of HF.	Through the MFTs deployment phase: 12 months of duration
Secondary	Proportion of febrile episode seen at HFL within 24 hours and tested for parasitemia.	Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF.	Through the MFTs deployment phase: 12 months of duration.
Secondary	Proportion of febrile episode seen at HFL within 24 hours with positive diagnostic test who were given ACT according to the MFTs strategy	Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF.	Through the MFTs deployment phase: 12 months of duration.
Secondary	Proportion of febrile episode seen at HFL within 24 hours with negative diagnostic test who did not received any antimalarial.	Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF.	Through the MFTs deployment phase: 12 months of duration.
Secondary	Proportion of febrile episode seen at HFL within 24 hours with negative diagnostic test who received an ACT.	Malaria diagnosis will done using malaria rapid diagnosis test (mRDT). Data will be obtained through health facility- based surveys using registers of HF.	Through the MFTs deployment phase: 12 months of duration.
Secondary	Proportion of febrile episodes treated with ACTs adhering to ACT treatment schedule (timing and doses) by HWs according to MFTs strategy	Household surveys (data will be collected in the community level through the KAP questionnaire).	During MFTs deployment phase at peak malaria season: 6 months of duration.
Secondary	Cost per additional febrile episode receiving prompt treatment or confirmed negative diagnosis	Data will be obtained using the cost data collection forms through health facility- based surveys.	Through the MFTs deployment phase: 12 months of duration.
Secondary	Cost per additional inappropriate antimalarial treatment avoided.	Data will be obtained using the cost data collection forms through health facility- based surveys.	Through the MFTs deployment phase: 12 months of duration.
Secondary	The cost per additional febrile episode appropriate managed for malaria with confirmed diagnosis	Data will be obtained using the cost data collection forms through health facility- based surveys.	Through the MFTs deployment phase: 12 months of duration
Secondary	The total cost per capita of intervention (provider perspective)	Data will be obtained using the cost data collection forms through health facility- based surveys.	Through the MFTs deployment phase: 12 months of duration
Secondary	The total cost per capita of intervention (societal perspective)	Data will be obtained using the cost data collection forms through household surveys (costing questionnaire administered at community level).	Through the MFTs deployment phase: 12 months of duration
Secondary	Cost to the HWs to participate to the MFTs strategy.	Data will be obtained using the cost data collection forms through at health facilities level.	Through the MFTs deployment phase: 12 months of duration.
Secondary	Proportion of episode of uncomplicated fever seen by HWs tested for malaria parasitemia.	Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF).	From the formative phase to the end of drugs deployment: 18 months duration.
Secondary	Proportion of uncomplicated fever episodes/malaria seen by HW, tested positive and treated with correct dose of ACT according to MFTs pilot program	Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF).	From the formative phase to the end of drugs deployment: 18 months duration.
Secondary	Proportion of febrile episodes treated with ACTs according to MFTs pilot programme by HWs provided with appropriate dosing advice	Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF).	From the formative phase to the end of drugs deployment: 18 months duration.
Secondary	Proportion of uncomplicated febrile episodes/malaria seen by HWs provided with advice on danger signs.	Data will be obtained through the health facility- based surveys (data collected at health facilities level using the registers of HF).	From the formative phase to the end of drugs deployment: 18 months duration.
Secondary	Incidence of uncomplicated febrile episode/malaria within 4 weeks preceding the surveys	Household surveys before and during the MFTs deployment using KAP questionnaire administered at the community level.	From the formative phase to the end of drugs deployment: 18 months duration.
Secondary	Proportion of uncomplicated febrile episode/malaria seen at health facility level before and during the MFTs deployment in the study area.	Data will be obtained through the health facility- based surveys (data collected at the health facility level using the registers of HF).	Through the MFTs deployment phase: 12 months of duration.
Secondary	Mortality rate related to febrile episode/malaria before and during the pilot MFTs deployment.	Data will be collected through the Health and demographic surveillance system mortality data and health facility- based surveys (data collected at the health facility level using the registers of HF).	From the formative phase to the end of drugs deployment: 18 months duration.
Secondary	Proportion of individuals with fever in the last four weeks for whom advice or treatment was sought	Household surveys using KAP questionnaire administered at the community level	From the formative phase to the end of drugs deployment: 18 months duration.
Secondary	Proportion of individuals with fever in the last four week who sought treatment at HFL within 24 hours	Household surveys using KAP questionnaire administered at the community level.	From the formative phase to the end of drugs deployment: 18 months duration.
Secondary	Source of advice or care for those suffering from fever in the last four weeks	Household survey using KAP questionnaire administered at the community level.	From the formative phase to the end of drugs deployment: 18 months duration.